BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3212420 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08161
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 16, 2013
    Report Date
    October 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT, THIS DEVICE WILL UNDER GO DETAILED LABORATORY TESTING IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. IT WAS NOTED THAT THIS OCCURRED DURING AN ATTEMPTED IMPLANT. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE REVEALED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO TESTING TO REVIEW THE DEVICE FUNCTIONS. THIS DEVICE HAS AN AUTOMATIC LEAD DETECTION FEATURE THAT REQUIRES AN IMPEDANCE RANGE BETWEEN 200 AND 2000 OHMS (INCLUSIVE) BEFORE THE DEVICE WILL AUTOMATICALLY SWITCH TO THE NOMINAL PARAMETERS AND START SENSING AND DELIVERING THERAPY. THE MEMORY OF THIS DEVICE CONFIRMED THAT THIS AUTO-DETECT FEATURE DID DETECT A LEAD. THE LEADS WERE THEN INSERTED INTO BOTH PORTS WITHOUT ISSUE AND BOTH RA AND RV PACING PULSES WERE PRESENT ON THE BENCH. THIS DEVICE PASSED ALL PACING, SENSING, IMPEDANCE MEASUREMENTS, AND RECORDING FUNCTIONS. IN CONCLUSION NO ISSUE FOUND WITH DEVICE; THE DEVICE PASSED BOTH MECHANICAL AND ELECTRICAL TESTS. THERAPY WAS AVAILABLE IN THIS DEVICE. THE DEVICE WAS ARCHIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A RECENT IMPLANT PROCEDURE, THIS PACEMAKER DID NOT DELIVER PACING WHEN CONNECTED TO THE IMPLANTED LEADS. MULTIPLE ATTEMPTS WERE MADE TO DISCONNECT AND RECONNECT THE DEVICE AND LEADS TO VERIFY PROPER CONNECTION, HOWEVER, THE DEVICE CONTINUED TO NOT DELIVER PACING. THE DECISION WAS MADE TO IMPLANT A NEW DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PACEMAKER WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312478 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND J174

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening